Video: The way we save time on case intake in Flex Databases Pharmacovigilance module

Every clinical trial role requires different information. CRAs need to track upcoming monitoring visits, Project Managers need study performance metrics, and clinical operations teams need enrollment and site activity data. In this video, see how Flex Databases CTMS allows every user to create a personalized dashboard without affecting other users. Learn how to add or […]

About Integrated Therapeutic Solutions Integrated Therapeutic Solutions (ITS) is a clinical research organization conducting multi-country clinical trials and supporting post-marketing needs across a growing sponsor portfolio. As case volumes increased, so did the complexity of managing pharmacovigilance activities from safety event intake and workflow tracking to regulatory reporting and cross-functional coordination with clinical operations teams. […]

Clinical industry has finally embraced AI, sponsors run decentralized trials and data is now collected in real time. But still one of the most critical workflows in every study – handling adverse events (AEs) – surprisingly depends on copy-paste. Most sponsors assume that if they have an Electronic Data Capture (EDC) system and a Pharmacovigilance […]

The pharmaceutical industry faces a familiar paradox: the tools that promise to make regulatory compliance faster and smarter also introduce the most complex new compliance questions. Nowhere is this more visible than in AI-powered Trial Master File (TMF) management. At Flex Databases, we have developed a validation framework rooted in GxP principles, risk-based thinking, and […]